Chemotherapy and Reduced Intensity Conditioning for Refractory Acute Myeloid Leukemia
A Phase II Single Arm Study of Cladribine, Cytarabine, Etoposide and Venetoclax Sequential With Reduced Dose Conditioning of Fludarabine, Busulfan and Melphalan or Total Marrow Radiation for Refractory Acute Myeloid Leukemia
This study is testing a new treatment plan that combines a special chemotherapy with a gentler conditioning method to see if it helps people with hard-to-treat acute myeloid leukemia feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, fludarabine |
| Locations | 3 sites (Shanghai, Shanghai Municipality and 2 other locations) |
| Trial ID | NCT05870995 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new treatment protocol for patients with refractory acute myeloid leukemia (AML) that combines a modified chemotherapy regimen of cladribine, cytarabine, and etoposide (CLAGE) with a reduced intensity conditioning regimen. The aim is to reduce toxicity and relapse rates associated with traditional treatments while improving disease-free survival. The study will assess the efficacy and feasibility of this approach in a multi-center phase II setting, incorporating the addition of Venetoclax to the treatment regimen. Patients will be monitored for their response to the treatment and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates include patients with refractory AML who have not achieved remission after multiple induction therapies and have specific donor matches for transplantation.
Not a fit: Patients with significant liver or renal dysfunction, or poor cardiac function, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced toxicity for patients with refractory AML.
How similar studies have performed: Previous studies have shown promise with similar chemotherapy and conditioning approaches, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with refractory AML: no remission after 2 induction therapy, relapsed AML within 6 months of 1st CR, relapse AML fail to having CR after reinduction therapy, multiple relapse and refractory relapse AML * patients with \>5% bone marrow blast by morphology or by LAIP flowcytometry at enrollment * patients with HLA-matched sibling donor, 9-10/10 matched unrelated donor or haplo-identical family donor * patients without active infection * informed consent provided Exclusion Criteria: * patients with abnormal liver function (enzyme \>2N or bilirubin \>2N) * patients with abnormal renal function (Scr \>1.5N) * patients with poor cardiac function （EF\<45%）
Where this trial is running
Shanghai, Shanghai Municipality and 2 other locations
- Blood & Marrow Transplantation Center, RuiJin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Department of Hematology, Shanghai No 6 Hospital — Shanghai, China (Recruiting)
- Shanghai ZhaXin Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Jiong HU
- Email: hj10709@rjh.com.cn
- Phone: 86-21-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.